SkylineDX’s test for evaluating metastatic risk in early-stage cutaneous melanoma patients has obtained breakthrough device designation from the US Food and Drug Administration (FDA).

The Dutch biotech’s Merlin clinicopathologic gene expression profile (CP-GEP) test functions as a predictive model and was developed alongside Mayo Clinic. By combining CP-GEP variables into a single integrated algorithm, the test stratifies cutaneous melanoma patients into high- or low-risk groups for metastases. This capability puts patients in a better position to receive appropriate surgical action, the company stated.